Class II · ModerateActive recall
amneal Metformin Hydrochloride Extended-Release Tablets
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberHF08618A 6/30/2020 HF08718A 6/30/2020 HF15418A 7/31/2020 HF15518A 7/31/2020 HH11818A 9/30/2020 HJ00818A 9/30/2020 HJ00918A 9/30/2020 HJ01018A 9/30/2020
Where it was soldNationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byAmneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 foreign manufacturer
| Distributed by / for | Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 |
| NDC | 65162-0178-11 |
Show the full FDA record
| Full product label | amneal Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000 tablets bottles, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Ahmedabad, 388213, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 NDC 65162-0178-11 |
| Recalling firm | Amneal Pharmaceuticals of New York, LLC |
| Distribution | Nationwide |
| Quantity | N/A |
| Recall initiated | 2020-05-29 |
| Report date | 2020-07-01 |
| Recall completed | — |
| Recall number | D-1353-2020 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Brookhaven NY United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.